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  • BSI
    BS ISO 29943-1:2017 Condoms. Guidance on clinical studies - Male condoms, clinical function studies based on self-reports
    Edition: 2017
    $526.05
    / user per year

Description of BS ISO 29943-1:2017 2017

This document is intended to help in the design, execution, analysis and interpretation of clinical function studies conducted in accordance with the requirements of ISO 23409 for male synthetic condoms.

These clinical studies compare the performance of a new male condom to an established male condom during vaginal intercourse (not anal intercourse). In particular, these studies are designed to assess acute failure events during use (i.e. clinical slippage and clinical breakage).

This document also provides direction on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers and regulatory bodies.

Certain clinical trial elements are not addressed in this document, including compensation, confidentiality of individuals and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in greater detail in ISO 14155 .



Standard NumberBS ISO 29943-1:2017
TitleCondoms. Guidance on clinical studies - Male condoms, clinical function studies based on self-reports
StatusUnder Review
Publication Date2017-07-12
Identical National Standard OfISO 29943-1:2017
DescriptorsDefects, Mixtures, Clinical testing, Synthetic rubber, Contraceptives, Statistical quality control, Performance, Packaging, Marking, Testing, Natural rubber, Dimensions, Contraceptive devices, Perforations, Design, Plastics, Latices, Personal health, Strength of materials, Contraceptive sheaths, Quality, Instructions for use
ICS11.200 Birth control. Mechanical contraceptives
CommitteeCH/157
ISBN978 0 580 85628 0
PublisherBSI
Pages52

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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